A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
19 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy adult older than 19 years and less than 55 years at the time of screening
BMI 18.5~29.9 kg/m2 and body weight more than 50kg
Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to two months after the last investigational product and not to provide sperm for men
Subjects who sign on an informed consent form willingly
Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease.
Subjects who have acute disease within 28 days prior to the first administration
Subjects who have history that may affect the ADME
Subjects who have clinically significant chronic disease
Women who are nursing, pregnant or positive on pregnancy test
Subjects who have clinically significant allergic diseases
Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Subjects who are known to be hypersensitive to the drug or its components
Subjects who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody)
Subjects with creatinine clearance <60 ml / min
Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range
Subjects who taked ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 1 week prior to the first administration
Subjects who can not eat standard meals provided by the institution.
Subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days
Subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration
Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days before the first administration (eg, ingestion of grapefruit juice>1 L / day)
Subjects who participate in the other clinical trial within 90 days prior to the first administration
Subjects who have a history of regular alcohol(alcohol>210g/week) or caffeine(caffeine>5 cups/day)
Subjects who smokes more than 10 cigarettes per day within 3 months or cannot discontinue smoking during the clinical trial
Subjects who is determined unsuitable to participate in this clinical trial by the investigator